NCT02678611

Brief Summary

This study will investigate the safety, tolerability and potential health benefits of the dietary supplement, Basis. There will be two doses of Basis compared to a placebo. One third of subjects will receive the low dose Basis, one third will receive the higher dose Basis and one third will receive placebo.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

6 months

First QC Date

February 3, 2016

Last Update Submit

July 28, 2016

Conditions

Safety: Healthy Subjects

Keywords

Healthy participantsDietary supplementSafetyTolerabilityOlder AdultsBasisNicotinamide ribosidePterostilbene

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    Assessment of blood pressure

    8 weeks

  • Safety Blood Parameters

    Assessment of safety blood parameters: CBC, electrolytes (Na, K, Cl), kidney function (creatinine), liver function (AST, ALT, GGT and bilirubin)

    8 weeks

  • Heart Rate

    Assessment of heart rate

    8 weeks

Secondary Outcomes (10)

  • Physiological Performance

    8 weeks

  • Physiological Performance

    8 weeks

  • Physiological Performance

    8 weeks

  • Body Weight

    8 weeks

  • Blood Pressure

    8 weeks

  • +5 more secondary outcomes

Other Outcomes (3)

  • Expression Profile of Peripheral Blood Mononuclear Cells

    8 weeks

  • Pain Assessment

    8 weeks

  • Endothelial Function

    8 weeks

Study Arms (3)

Basis 250

EXPERIMENTAL
Dietary Supplement: Basis 250

Basis 500

EXPERIMENTAL
Dietary Supplement: Basis 500

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Basis 250DIETARY_SUPPLEMENT
Basis 250
Basis 500DIETARY_SUPPLEMENT
Basis 500
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females 60 to 80 (inclusive) years of age
  • Body Mass Index (BMI) must be 18 to 35 kg/ m2 (±1 kg/m2)
  • Be able to make scheduled office visits 4 times during the study
  • Willing to follow the instructions and complete multiple study questionnaires and assessments
  • Agrees to avoid taking Vitamin B3 (Niacin, Nicotinic acid or niacinamide) supplements or multivitamins 14 days prior to randomization and for the duration of the study period
  • Healthy otherwise as determined by laboratory results and medical history
  • Has given voluntary, written, informed consent to participate in the study

You may not qualify if:

  • History of any significant chronic disease or any clinically active illness within 3 months of study entry, including any history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease. Clinical significance of disease will be assessed by the Qualified Investigator and eligibility determined.
  • Significant or untreated medical disorders including recent myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, AIDS, malignancy, epilepsy, and recent cerebrovascular disease
  • Subjects with or who have recently experienced a traumatic injury, infections or undergone surgery
  • Subjects with history of pellagra or niacin deficiency
  • Taking lipid lowering drugs
  • Use of natural health products containing Nicotinamide riboside within 14 days prior to randomization and during the course of the study
  • History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Volunteers with cancer in full remission more than 5 years after diagnosis are acceptable
  • Has participated in any clinical trial with an investigational medicinal product within the past three months prior to the first dose in the current study
  • Unstable medical conditions
  • Alcohol use \>2 standard alcoholic drinks per day
  • History of alcoholism or drug abuse within 1 year prior to screening
  • History of significant allergies
  • Allergy or sensitivity to any of the investigational product ingredients
  • Use of medicinal marijuana
  • Clinically significant abnormal laboratory results at screening
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

  • Tetyana Pelipyagina, MD

    KGK Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 10, 2016

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

CA(1)